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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K925999
Device Name SWEMED NEEDLE GUIDE
Applicant
Swemed Lab Intl.
150 N. Michigan Ave.
Suite 1200
Chicago,  IL  60601
Applicant Contact SVEN E SIEVERS
Correspondent
Swemed Lab Intl.
150 N. Michigan Ave.
Suite 1200
Chicago,  IL  60601
Correspondent Contact SVEN E SIEVERS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/27/1992
Decision Date 10/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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